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Epigenetic Markers of B-Cell Function in Low Birth Weight Infants

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ClinicalTrials.gov Identifier: NCT00925925
Recruitment Status : Completed
First Posted : June 22, 2009
Last Update Posted : May 12, 2015
Sponsor:
Collaborator:
Department of Health and Human Services
Information provided by:
University of Utah

Tracking Information
First Submitted Date June 18, 2009
First Posted Date June 22, 2009
Last Update Posted Date May 12, 2015
Study Start Date June 2009
Actual Primary Completion Date May 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 19, 2009)
Characterize and compare the Low Birth Weight(LBW) B lymphocyte subtype B1b with that of Normal Birth Weight(NBW) infants. [ Time Frame: 2 years ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: June 19, 2009)
Characterize CD19 and CD5 epigenetic regulation in LBW infants as compared to NBW infants. [ Time Frame: 2 years ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Epigenetic Markers of B-Cell Function in Low Birth Weight Infants
Official Title Epigenetic Markers of B-Cell Function in Low Birth Weight Infants
Brief Summary

Low birth weight (LBW) status (< 10% for gestational age at birth) is associated with increased risk for diseases such as type II diabetes mellitus, hypertension, chronic obstructive pulmonary disease and coronary artery disease in adults, and represents one example of the "fetal onset of adult disease" hypothesis. Recent data strongly associates LBW status with impaired innate and adaptive immunity leading to increased risk for severe infections during adolescence or early adulthood. Animal studies suggest that the ratio of certain B lymphocyte subpopulations, the B1a and B1b cells, determines whether deficits in immunity occur.

This study will determine the ratio of B1b to B1a lymphocyte subpopulations in the cord blood of infants born LBW in the late preterm to term gestations (> 34 weeks at birth) and compare those ratios with those of normal birth weight (NBW) controls in a nested case control study design.

Furthermore, animal studies suggest that the expression patterns of CD5 and CD19 proteins determines the cellular phenotype of the B lymphocyte, that of a B1a or a B1b cell, and that the regulatory regions controlling their expression are epigenetically vulnerable. The investigators will therefore isolate DNA and RNA from both B lymphocyte subpopulations and determine whether epigenetic changes to the regulatory regions of the genes coding for CD5 and CD19 protein expression occur in LBW lymphocyte subpopulations as compared to the lymphocytes from NBW infants.

This proposal will be the first human study to examine epigenetic determination of a maladaptive phenotype following LBW status at birth in a specific cell type leading to a specific impairment of innate and adaptive immunity.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Blood will be stored as frozen mRNA isolates if parents consent to tissue banking.
Sampling Method Non-Probability Sample
Study Population Term or near-term infants born at less than or equal to 10% normal birth weight for gestation.
Condition
  • Low Birth Weight
  • Small for Gestational Age
  • Immunodeficiency
Intervention Other: Cord blood collection for analysis
Cord blood will be collected from the placentas at delivery for analysis
Study Groups/Cohorts
  • Normal Birth Weight (NBW)
    Term, healthy infants born at normal birth weights
    Intervention: Other: Cord blood collection for analysis
  • Low Birth Weight (LBW)
    Infants born at > or equal to 34 0/7 weeks with a birth weight at < or equal to 10% for gestational age at birth (Small for Gestational Age, SGA)
    Intervention: Other: Cord blood collection for analysis
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: May 11, 2015)
64
Original Estimated Enrollment
 (submitted: June 19, 2009)
160
Actual Study Completion Date May 2012
Actual Primary Completion Date May 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Infants delivered at University of Utah Health Sciences Center
  • For LBW group:

    • Gestational age > or = to 34 0/7 weeks
    • Birth weight < or = to 10% for gestational age
  • For NBW group:

    • Term infant controls delivered without complication
  • Adequate cord blood sample obtained directly after birth
  • Parents or guardians must have signed informed consent

Exclusion Criteria:

  • Infants with major congenital anomalies will be excluded
Sex/Gender
Sexes Eligible for Study: All
Ages up to 2 Hours   (Child)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00925925
Other Study ID Numbers 35580
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Christian Con Yost, University of Utah
Study Sponsor University of Utah
Collaborators Department of Health and Human Services
Investigators
Principal Investigator: Christian C Yost, M.D. University of Utah
PRS Account University of Utah
Verification Date June 2012